Z-2886-2026 Class II Ongoing
FDA device recall Z-2886-2026 was initiated by United Orthopedic Corp. on May 20, 2026 and is designated Class II. Reason for recall: Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. The recall status is ongoing. Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2026
- Initiation Date
- May 20, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
Reason for Recall
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Distribution Pattern
US Nationwide distribution in the states of Texas and Michigan.
Code Information
Product Number; UDI-DI Code; Lot Code: Product number 9323-5335; UDI-DI 04719886906554; Lot number 25FB64 Product number 9323-5337; UDI-DI 04719886906578; Lot number 25FB48 Product number 9323-5339; UDI-DI 04719886906592; Lot number 25FB52 Product number 9323-5336; UDI-DI 04719886906561; Lot number 25FB65 Product number 9323-5338; UDI-DI 04719886906585; Lot number 25FB49 Product number 9323-5340; UDI-DI 04719886906608; Lot number 25FB53